BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INTERSTIM NEUROSTIMULATOR

    MDR report key: 4240573 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03277
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 20, 2012
    Report Date
    February 19, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PREVIOUSLY REPORTED FOR SERIOUS INJURY DUE TO UNEXPECTED SURGICAL INTERVENTION AS A RESULT OF A MALFUCTION. HOWEVER, ADDITIONAL INFORMATION CLARIFIED THAT NO MALFUNCTION WAS OBSERVED AND THE EXPLANT WAS ELECTIVE, THEREFORE NO SERIOUS INJURY OCCURRED EITHER. NO INFORMATION MAKES EVENT NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION RECEIVED;

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S ¿IMPLANT FAILED¿ AND THEREFORE WAS REMOVED. THE PATIENT HAD ¿6,3¿ ALIQUOTS ON THE FIRST VISIT AND ¿8,1¿ ALIQUOTS, BUT THE MEANING OF WHICH WAS UNCLEAR. CAUSE, PATIENT OUTCOME, SYMPTOMS, AND MEANING BEHIND ALIQUOTS WERE NOT KNOWN. FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S SYMPTOMS DID NOT IMPROVE, AND THAT THE DEVICE ITSELF "DID NOT FAIL." NO MALFUNCTIONS WERE OBSERVED, AND THE ONLY SYMPTOMS WERE UNIMPROVED URINARY SYMPTOMS OF URGENCY, FREQUENCY, AND URGENCY INCONTINENCE. THE PATIENT HAD AN UNCOMPLICATED DEVICE REMOVAL. IT WAS CLARIFIED THAT THE ALIQUOTS PREVIOUSLY REPORTED WERE URINE SAMPLES TO BE RUN LATER FOR THE CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723948 UNKNOWN INTERSTIM NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention